Temperature of blood/coolers upon receipt

[EAB81]

I'm updating policies, and I'm trying to find exactly what AABB or CAP states about taking temperatures upon receipt of blood from the blood supplier.

I need to know if the agencies state that the temp has to be taken each time or exactly how often with coolers being validated by the blood center. Can anyone help?

[SMILLER]

Glancing at the AABB Standards (31st ed), they only state that incoming products shall be "inspected, tested as necessary" before use.   In our case, we log the temp as "acceptable" for RBC products received from our supplier if they arrive on wet ice.  (and labels are legible, units not leaking, etc.)  Likewise, for FFP, on dry ice, and so on.  This is written into our procedure for checking in blood products.  I do not believe we have ever had to "validate" coolers sent from our blood supplier, although we have to do this with our own coolers used for transport.

Not sure about CAP or FDA regs, they may be more strict.

Scott

[Ward_X]

3 hours ago, SMILLER said:

Glancing at the AABB Standards (31st ed), they only state that incoming products shall be "inspected, tested as necessary" before use.   In our case, we log the temp as "acceptable" for RBC products received from our supplier if they arrive on wet ice.  (and labels are legible, units not leaking, etc.)  Likewise, for FFP, on dry ice, and so on.  This is written into our procedure for checking in blood products.  I do not believe we have ever had to "validate" coolers sent from our blood supplier, although we have to do this with our own coolers used for transport.

Not sure about CAP or FDA regs, they may be more strict.

Scott

Isn't there only restrictions on the packaging for products? ____ inches of insulation, ____ type of ice pack (whether wet or dry), etc.  If the products arrive as following packed guidelines, would you need to check necessarily?

Reagents received usually come with those temperature validating color-changing window cards. Interesting how a similar thing doesn't come with blood products...

[applejw]

My interpretation is that containers used for transporting blood products must be validated to ensure that the blood products are maintained at appropriate temperatures including extreme ambient temperatures (winter and summer).  This validation would need to be done by the blood supplier since it is their container that is used for the transport and would be verified by the FDA during their routine inspections of blood manufacturers.

As a recipient of incoming critical supplies (blood products, reagents, etc...), I must have established criteria that are used to verify that the incoming products are acceptable. If my criteria include measuring the temperature of all or part of a blood shipment, then that needs to be performed at the time the shipment is received. My blood supplier must pack products to maintain the correct temperature for a reasonable time period so that, should I choose to measure it, the units would be at the appropriate temperature.

[David Saikin]

My supplier validates their shipping boxes.  Coolers are a whole other story.

I have never seen a standard requiring temperature of product rec'd from the supplier. (see the quote above - the AABB standard). 

Edited July 19, 2019 by David Saikin

[EAB81]

Well, the issue came about from our Quality Department. They wanted to know that our supplier was shipping products at the appropriate temperature and wanted documented proof. So, our pathologist wanted me to update and cite the standard in the policy <insert confused shrug>.  Our current policy just states that RBCS should be shipped at a temp between 1 and 10, and there's no need to verify temperature unless a temperature issue is suspected. I contacted the supplier for their verification of coolers, and they told me that their method was to have the courier delivering products have a blood bank tech verify a temp. They would document that on a 3-ply sheet for which we would get a copy. Well, we did that when we were an exchange hospital, but we haven't been an exchange hospital in a few years. None of the techs can recall being asked to verify temps. So, I'm not exactly sure where to go from here.

[ElinF]

Twice a year our suppliers send a slip of paper in the transport container asking us to take the temp and fax it to them. 

[SMILLER]

20 hours ago, EAB81 said:

Well, the issue came about from our Quality Department. They wanted to know that our supplier was shipping products at the appropriate temperature and wanted documented proof. So, our pathologist wanted me to update and cite the standard in the policy <insert confused shrug>.  Our current policy just states that RBCS should be shipped at a temp between 1 and 10, and there's no need to verify temperature unless a temperature issue is suspected. I contacted the supplier for their verification of coolers, and they told me that their method was to have the courier delivering products have a blood bank tech verify a temp. They would document that on a 3-ply sheet for which we would get a copy. Well, we did that when we were an exchange hospital, but we haven't been an exchange hospital in a few years. None of the techs can recall being asked to verify temps. So, I'm not exactly sure where to go from here.

Can you get a copy of the policy from your supplier that they use to validate their shipping containers?  Type up a letter for your pathologist to approve explaining it and give that to your Quality people.  Then if they want something more, ask them to show you the regulatory standard they are worried about.

Scott

Edited July 20, 2019 by SMILLER

[EAB81]

On ‎07‎/‎20‎/‎2019 at 6:59 AM, SMILLER said:

Can you get a copy of the policy from your supplier that they use to validate their shipping containers?  Type up a letter for your pathologist to approve explaining it and give that to your Quality people.  Then if they want something more, ask them to show you the regulatory standard they are worried about.

Scott

Well, that's what I originally called and asked them-- if I could have a copy of their policy. I've left an email again today because I've yet to receive anything from them. In the mean time, we are going to start taking temps of the coolers ourselves at random and documenting. We are within our inspection time for CAP and AABB. Hopefully, a last minute effort is better than none. I will, however, be contacting quality to see what standard they are concerned with. My money will be on probably Joint Commission.